Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01697202
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2012-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fatigue in Rheumatoid Arthritis - Longitudinal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '4 times during the course of the study up to one year', 'description': 'patient administered questionnaire'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '4 times during the course of the study up to one year', 'description': 'patient administered questionnaire'}, {'measure': 'Activity limitations', 'timeFrame': '4 times during the course of the study up to one year', 'description': 'patient administered questionnaire'}, {'measure': 'Disease activity', 'timeFrame': '4 times during the course of the study up to one year', 'description': 'Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28)'}, {'measure': 'Health related quality of life', 'timeFrame': '4 times during the course of the study upto one year', 'description': 'patient administered questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg, Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnose of RA, age 20-65 years,\n\nExclusion Criteria:\n\n* other serious physical or mental illness'}, 'identificationModule': {'nctId': 'NCT01697202', 'briefTitle': 'Fatigue in Rheumatoid Arthritis - Longitudinal Study', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Fatigue in Rheumatoid Arthritis - Longitudinal Study', 'orgStudyIdInfo': {'id': 'GoteborgU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}